Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI

ST Segment Elevation Myocardial Infarction Clinical Trial

— NOSLOWFLOW-?  

Official title:

Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03406819
• Other study ID #: KS-2017-176
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2018
• Last updated: January 19, 2018
• Start date: January 7, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Chunguang Qiu, Phd
• Phone: +86-13803898806
• Email: qcg123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset

• Continued ischemic chest pain > 30min

• ST-segment elevation = 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)

• Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)

• Primary coronary artery angiography was planned.

Exclusion Criteria:

• Emergency thrombolytic therapy was performed before primary coronary artery angiography

• Cardiogenic shock with no response to hypervolemic treatment or vasopressor

• Severe cardiomyopathy or valvular disease requiring intervention

• Coronary ectasia

• Severe heart failure

• Contraindication or allergy to antiplatelet drugs

• Contraindication or allergy to experimental drugs

• Unable to receive at least 1 year of dual antiplatelet therapy

• Active bleeding or extreme-risk for major bleeding

• Severe liver or renal failure

• Life expectancy < 1 year

• Unable or unwilling to provide informed consent

• Women of child bearing potential

• Under 18 years of age

• Hemoglobin < 90g/L

• Platelet count < 100×10^9/L

• Can not cooperate (with mental disorders or cognitive disorders)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Primary Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

Drug:
• Nitroprusside Sodium
Intracoronary infusion 50~100µg each time (repeated)
• Tirofiban Hydrochloride
Intracoronary infusion 10µg/kg for single time
• Heparinized saline
Intracoronary infusion 2ml for single time

Locations

Country	Name	City	State
China	Anyang District Hospital	Anyang	Henan
China	The 99th Central Hospital of the People's Liberation Army	Jiaozuo	Henan
China	The People's Hospital of Jiaozuo	Jiaozuo	Henan
China	Jincheng People's Hospital	Jincheng	Shanxi
China	The second people's Hospital of Jiyuan	Jiyuan	Henan
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	Kaifeng Central Hospital	Kaifeng	Henan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Lushan People's Hospital	Lushan	Henan
China	Nanyang City Center Hospital	Nanyang	Henan
China	Pingmei Shenma Medical Group General Hospital	Pingdingshan	Henan
China	The Second People's Hospital of Pingdingshan	Pingdingshan	Henan
China	Puyang Oilfield General Hospital	Puyang	Henan
China	Puyang People's Hospital	Puyang	Henan
China	Yellow River Sanmenxia hospital	Sanmenxia	Henan
China	The First People's Hospital of Shangqiu	Shangqiu	Henan
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xinyang Central Hospital	Xinyang	Henan
China	Yanshi People's Hospital	Yanshi	Henan
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The First People's Hospital of Xinmi	Zhengzhou	Henan
China	Zhengzhou Cardiovascular Hospital	Zhengzhou	Henan
China	Zhengzhou Central Hospital	Zhengzhou	Henan
China	Zhengzhou First People's Hospital	Zhengzhou	Henan
China	Zhoukou Central Hospital	Zhoukou	Henan
China	The First People's Hospital of Zhumadian	Zhumadian	Henan
China	Zhumadian Central Hospital	Zhumadian	Henan

Sponsors (28)

Lead Sponsor

Collaborator

The First Affiliated Hospital of Zhengzhou University

Anyang Regional Hospital, Huaihe Hospital of Henan University, Jincheng People’s Hospital, Kaifeng Central Hospital, Lushan People’s Hospital, Nanyang Central Hospital, People’s Hospital of Zhengzhou, Puyang Oil Field General Hospital, Puyang People's Hospital, Shenma Medical Group General Hospital, The 99th Central Hospital of the People's Liberation Army, The First Affiliated Hospital of Henan University of Science and Technology, The First Affiliated Hospital of Xinxiang Medical University, The First People's Hospital of Shangqiu, The First People's Hospital of Xinmi, The First People's Hospital of Zhumadian, The Peoples' Hospital of Jiaozuo City, The second people's Hospital of Jiyuan, The Second People's Hospital of Pingdingshan, Xinyang Central Hospital, Yanshi People’s Hospital, Yellow River Sanmenxia hospital, Zhengzhou Cardiovascular Hospital, Zhengzhou Central Hospital, Zhengzhou First People’s Hospital, Zhoukou Central Hospital, Zhumadian Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation	Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.	1 minute after stent implantation
Primary	Coronary artery flow using TIMI flow grade after balloon dilatation	Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.	1 minute after balloon dilatation
Primary	Coronary TIMI frame count after stent implantation	A continuous measurement assessing flow in the epicardial arteries.	1 minute after stent implantation
Primary	Coronary TIMI frame count after balloon dilatation	A continuous measurement assessing flow in the epicardial arteries.	1 minute after balloon dilatation
Primary	Slow flow / no-reflow phenomenon after stent implantation	Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.	1 minute after stent implantation
Primary	Slow flow / no-reflow phenomenon after balloon dilatation	Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.	1 minute after balloon dilatation
Primary	ECG ST-segment fall more than 50%	The extent of ST segment elevation was reduced by more than 50%	in 2 hours post-PCI
Secondary	Main adverse cardiovascular and cerebrovascular events (MACCE)	Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc.	at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI